OMGA - Omega liver cancer drug OTX-2002 gets FDA orphan drug status
- The U.S. Food and Drug Administration (FDA) granted orphan drug designation to Omega Therapeutics' ( NASDAQ: OMGA ) OTX-2002 to treat hepatocellular carcinoma (HCC), a type of liver cancer.
- The company noted that the first patient was dosed in phase 1/2 trial, dubbed MYCHELANGELO I, of OTX-2002 as a monotherapy and in combination with standard of care therapies in patients with relapsed or refractory HCC and other solid tumor types.
- The FDA grants orphan drug status to therapies which treat or prevent rare diseases that affect fewer than 200K people in the U.S. The designation provides certain incentives, including seven years of market exclusivity, if approved.
- OMGA -4.99% to $4.95 premarket Nov. 2
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Omega liver cancer drug OTX-2002 gets FDA orphan drug status